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To assess whether social support moderates the effect of the intervention on mental HRQoL, we performed a regression analysis that included the interaction term between the intervention variable and the baseline score for social support.
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All models included time and an interaction term between time and the intervention variable in order to assess time specific intervention effects.
The magnitude and significance of the coefficients on the interactions between the covariates and the intervention variable will provide estimates of cost-effectiveness of the surgical options by participant subgroup.
During hormonal therapy patients report mood swings and increased fatigue, which can be expected to influence the relationship between the intervention and the outcome variable.
Specifically, we will model each dependent variable first using the main effects of the barrier variables and of the YPT intervention, and then add two-way interactions between the intervention and the barrier variables.
Multivariate analysis will consist of a regression model using the follow-up results as outcome (dependent) variables, to be compared between the intervention versus control groups as independent variables, with the baseline results as covariates supplemented by variables that were found to be statistically significant in previous univariate analyses.
The difference for the primary outcome variable between the intervention groups and the control group is based on a power of 0.90 and an alpha of 0.05.
With an alpha error of 5%, this would have a power of 80% to detect a difference of 25% in the primary outcome variable between the intervention (group counseling) and the control (individual counseling) arms.
Chi-square and t-tests were used to detect differences between the intervention and control groups for categorical variables and continuous variables (transformed to improve normality if necessary), respectively.
To increase the likelihood of comparability between intervention groups, we excluded small studies (n < 50 per treatment arm) where key data regarding potentially outcome-relevant clinical variables between the intervention groups at baseline were missing (i.e. age, sex, severity of the illness (history and at baseline)) (Pfennig et al. [2012]).
There were no other significant differences in any of the tested variables between the intervention and the control arm.
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